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A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension

This study has been completed.
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Information provided by (Responsible Party):
Farmoquimica S.A. Identifier:
First received: September 18, 2009
Last updated: April 16, 2015
Last verified: March 2012
The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.

Condition Intervention Phase
Otitis Externa Drug: Cipro HC Drug: Ciprofloxacin HCl and Hydrocortisone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicentric, Double Blind, Randomized, Parallel Comparative Study Between Ciprofloxacin HCl 2 mg/mL + Hydrocortisone 10 mg/mL Ear Suspension and Cipro HC®, for the Assessment of Efficacy and Safety in Patients With Otitis Externa.

Resource links provided by NLM:

Further study details as provided by Farmoquimica S.A.:

Primary Outcome Measures:
  • Cure (reduced pain, swelling and otorrhea) [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Identification of possible side effects [ Time Frame: 7 days ]

Enrollment: 224
Study Start Date: April 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cipro HC
Reference product
Drug: Cipro HC
Cipro HC (Ciprofloxacin HCl and Hydrocortisone)
Experimental: Ciprofloxacin HCl and Hydrocortisone
Test product
Drug: Ciprofloxacin HCl and Hydrocortisone
Ciprofloxacin Hydrochloride and Hydrocortisone
Other Name: Otociriax

Detailed Description:

Phase III, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study.

Population: 224 patients with external otitis , men and women aged between 1 - 70 years.

Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure).

Secondary endpoint: The endpoint will be the identification of the side effects of medication use.


Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed of the nature of the study and given written informed consent;
  • Patients with acute otitis externa;
  • Intact tympanic membrane.

Exclusion Criteria:

  • Known allergy or sensitivity to Ciprofloxacin Hydrochloride and Hydrocortisone;
  • Patient has the tympanic membrane not intact;
  • Diabetes
  • Bilateral Acute Otitis Externa;
  • Pregnant or lactating patients;
  • Overt fungal Acute Otitis Externa;
  • Other diseases of the ear
  • Current Infection requiring systemic antimicrobial therapy.
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00980876

Clínica Quiron
Campinas, São Paulo, Brazil, 13087-000
Sponsors and Collaborators
Farmoquimica S.A.
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Principal Investigator: Agricio N. Crespo, Phd Clínica Quiron
  More Information

Responsible Party: Farmoquimica S.A. Identifier: NCT00980876     History of Changes
Other Study ID Numbers: STPh 09/08
Study First Received: September 18, 2009
Last Updated: April 16, 2015

Additional relevant MeSH terms:
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Ciprofloxacin, hydrocortisone drug combination
Anti-Inflammatory Agents
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on September 19, 2017